A million surgical procedures are performed annually to correct stress urinary incontinence (SUI) in 400,000 American women and 600,000 women abroad. In this context, “stress” refers to sneezing, straining and similar actions that can cause incontinence. A large percentage of these women are unable to void satisfactorily post-operatively and require a catheter to drain the bladder for several days or weeks. Post-operative urinary retention (PUR) occurs in up to forty-one percent (41%) of cases (1, 2). PUR is generally only a temporary event lasting a few days to weeks, but it can be painful, frightening and distressing, and it can complicate postoperative care. In these situations, the suprapubic catheter placed inside-out (I/O)—by passing a sound through the urethra, bladder and abdomen, attaching a catheter to the sound, bringing the catheter into the bladder, and connecting the catheter to drainage—is superior to all other methods. This procedure (called “suprapubic cystotomy”) is almost always performed during surgery as opposed to post-operatively because it would require anesthesia and return to the operating room for a second operation.
Suprapubic catheterization may also be necessary with surgeries involving repair of pelvic prolapse, which refers to relaxation of the pelvic floor in a female patient and the descensus or drooping of the bladder, urethra, rectum and/or uterus—whether or not the patient also requires SUI surgery. Approximately seventy percent (70%) of women who undergo SUI surgery also require reconstructive vaginal surgery for repair of pelvic prolapse (3). Thirty percent (30%) of women in the United States and other developed countries experience pelvic prolapse at some point in their lives, and eleven percent (11%) of all women with this condition will require surgery to correct it. Twenty-nine percent (29%) of women who are operated on for prolapse repair will require repeat surgery (4). As these numbers illustrate, the need for a fast and reliable catheter capture method in women undergoing surgery to correct SUI and/or pelvic prolapse is widespread.
When a well functioning suprapubic catheter is in place, accurate post-operative evaluation of bladder recovery and emptying is relatively easy. A typical procedure involves leaving the suprapubic catheter plugged for the first two to three postoperative weeks so that the patient can attempt to void normally and the residual urine can be checked without discomfort. Residual urine is checked by keeping the suprapubic catheter clamped so that the bladder will fill, having the patient void when she feels the need to void, and then removing the plug from the catheter and measuring the urine that drains out of the catheter. When the post-void residual urine is consistently less than 60 ml, the catheter may be removed safely because it is highly unlikely the patient will develop (or redevelop) urinary retention. If urinary retention is still present two to three weeks after surgery, then the catheter can be removed and intermittent self-catheterization (ISC) commenced (5).
ISC is used in one of two situations: (1) when the patient has failed the post-operative trial of voiding and the suprapubic catheter has been removed; or (2) immediately after surgery when a suprapubic catheter was not used. In the former situation, when the patient remains unable to void satisfactorily two to three weeks after surgery, the suprapubic catheter is usually removed, and the patient begins ISC three to four times daily after voiding. With ISC, a new catheter is passed by the patient through the urethra into the bladder each time she voids (to measure the residual urine). When post-void residual urines are low, the patient is free to return to normal voiding without catheters.
The preferred approach is to teach the patient pre-operatively to perform ISC three to four times daily. Many women, however, are either unable to learn or do not want to place a catheter blindly into the urethra and bladder, through a painful, freshly operated area with sutures that are oozing blood and serum (5). The developed consensus among medical practitioners is to place a suprapubic catheter at surgery if the patient has not demonstrated her ability or willingness to perform ISC (1, 6). Passage of a suprapubic catheter from the inside-out (I/O) during surgery is believed to be the best solution because it is safer than passing a catheter from the outside-in (O/I). Furthermore, the I/O technique allows physicians to use larger catheters, which are more reliable in terms of draining the urine. Smaller catheters (i.e., catheters with a smaller diameter—not length) are used with the O/I techniques because O/I can cause perforation of the bowel or peritoneal cavity, and larger tubes (or catheters) would lead to a higher complication rate. The I/O method, despite its advantages, has been awkward and difficult with current devices.
The most commonly employed technique is outside-in (O/I) suprapubic “punch” cystotomy, which entails passage of a small (width) catheter through a small trocar that is “punched” through the abdomen into the bladder. In comparison to I/O techniques, the O/I technique is simple, cheap and easy, but bladder drainage is unreliable because the small catheters often kink or become obstructed when small blood clots enter or form inside the catheter. As a result, the O/I technique is never used for permanent catheterization because of unreliable urine drainage. All O/I devices are more prone to unrecognized bowel or peritoneal perforation with serious secondary complications than the I/O devices. For these reasons, the O/I technique has been condemned by Drs. Ed McGuire and J. Q. Clemens in Campbell's Urology, 8.sup.th edition, p. 1160. The applicant believes that an important reason for the current popularity of O/I techniques is because the I/O devices that are currently available are poorly designed, awkward and difficult to use. Moreover, catheter capture is difficult to achieve with these I/O devices.
Currently, the safest and the only reliable method for inserting I/O catheters is to pass a hollow stainless steel device (called a “sound”) through the urethra and bladder and then through the abdominal wall, at which point the catheter is affixed to the sound and drawn back into the bladder. The catheter is then inflated and connected to drainage. Each of the devices currently on the market, however, has serious drawbacks. One drawback that is common to all of these devices is that the tip of each device has a short “throw” so that it is difficult to pass the tip of the device through the abdominal wall. When the device is too short to advance through the abdominal wall, catheter capture (i.e., securing or affixing the catheter) becomes extremely difficult. Another drawback is that existing catheter capture methods do not work. If the catheter cannot be captured, then the physician will have to insert an indwelling urethral Foley catheter immediately after surgery, or the surgeon will have to make an incision through the abdomen and into the bladder in order to place the suprapubic catheter. Despite the flaws in current technology, there have been no significant developments in catheter placement devices for more than twenty (20) years, although there are a number of patents in this area.
U.S. Pat. No. 5,152,749 (Giesy et al., 1992), U.S. Pat. No. 5,232,443 (Leach, 1993) and U.S. Pat. No. 5,348,541 (Lyell, 1994) all describe suprapubic catheter placement devices. The Giesy device is limited in that it only describes two means of coupling the catheter to the placement device. These two means are (i) a loop on the catheter and an indentation on the placement device and (ii) a ball and stem on the catheter that fit into a groove and cavity on the placement device. A sheath slides over the device to hold the coupling mechanism in place. The Leach device is limited in that it has a short “throw” and uses a jaw mechanism to capture the catheter. The jaw mechanism becomes wider after the catheter is enclosed within the jaws, making it more difficult for the catheter to be pulled safely through a small hole in the bladder and potentially resulting in loss of the catheter. Loss of the catheter requires the surgeon to start all over again, subjecting the patient to further unnecessary trauma. The Lyell device is limited in that the only catheter capture means it describes is a hook on the end of a flexible wire. The hook couples with the lateral hole provided in the catheter—not with the hole that extends longitudinally at the tip of the catheter, as in one embodiment of the present invention. The various embodiments of the present invention are superior to the embodiments described above in terms of efficacy and ease of use.
Because of the problems associated with current suprapubic catheter placement technologies, many patients have been placed on urethral catheterization immediately after surgery instead of suprapubic bladder catheterization during surgery. Urethral catheterization involves placing the catheter directly into the bladder through the urethra. Urethral catheterization is simpler, cheaper and easier than suprapubic catheterization, but it has its disadvantages. Specifically, residual urine is impossible to determine while an indwelling urethral catheter is present to drain the bladder because the catheter fills the urethra and makes it impossible to void. Patients are much more comfortable with suprapubic catheters than with urethral catheters exiting the genitalia, and sexual relations are impossible with a urethral catheter in place. Thus, the preferred alternative is still I/O suprapubic catheter placement, but current methods and available devices are inadequate—particularly in cases involving women, where the distance from the bladder to the abdominal is often greater than in men.
Although designed initially to solve problems relating to the use of other catheter placement devices in women, the catheter capture device of the present invention can be used with both women and men. Suprapubic catheterization is often indicated for those men and women who are unable to empty their bladders or who have lost control of their bladders and are required to live in diapers—patients found commonly in nursing homes. These patients include men with high-grade prostate obstruction and men and women with neurologic diseases (such as multiple sclerosis, stroke, Parkinson's disease, Alzheimer's disease and senility) that destroy bladder control and bladder emptying. Most of these patients do not have suprapubic catheterization because it would be a difficult and formidable procedure for them as currently performed.
Accordingly, it is an object of the present invention to provide a fast and reliable method of capturing a suprapubic catheter for placement in the bladder. It is a further object of the present invention to provide a catheter capture device with a “throw” that is sufficiently long to pass through the bladder, abdominal wall and skin easily and rapidly. It is a further object of the present invention to provide a catheter capture device with a modified trocar tip that is suitable for passing over a wire, traversing the abdominal wall, and passing into the bladder. It is a further object of the present invention to provide a catheter capture device that can be used effectively in both women and men whenever suprapubic catheterization is indicated and an abdominal incision is not employed. It is a further object of the present invention to provide a catheter capture device that affords reliable long-term catheter drainage. It is a further object of the present invention to allow placement of permanent suprapubic catheters for chronically ill and elderly men and women instead of condemning them to diapers or long-term urethral catheterization in nursing homes. It is a further object of the present invention to provide a device and method for placing a suprapubic catheter in the morbidly obese. It is a further object of the present invention to provide a catheter capture device that is disposable.